Home SPL Set DailyMed SPL v2 SPL SPL Set ID eb7c418b-8bee-26a3-e053-2a95a90a4e96 Route TOPICAL Published Effective Date 2022-10-20 Document Type 34390-5 HUMAN OTC DRUG LABEL Drug Facts Composition & Product Active Ingredients Arctium Lappa Root (0.012 g) Polyacrylamide (crosslinked; 0.01-0.2 Mole Percent Bisacrylamide) (0.8 g) Laureth-7 (0.12 g) Peg/ppg-20/6 Dimethicone (1.372 g) Alcohol (0.08 mL) Glycerin (0.048 g) Cetearyl Ethylhexanoate (4 g) Limonene, (+)- (0.08398 g) Panthenol (0.1 g) Imidurea (0.9 g) Fd&c Yellow No. 5 (0.00024 g) Riboflavin (0.6 g) Phenoxyethanol (0.00004 g) Fragrance 13576 (0.00012 g) Water (0.0252 g) Cetostearyl Alcohol (123.55598 mL) Propylene Glycol (26 g) Mineral Oil (10.148 g) Ethylhexylglycerin (6 g) Methylchloroisothiazolinone (0.0028 g) Methylisothiazolinone (0.045 g) Hops (0.15 g) Tioxolone (0.002 g) Propylparaben (0.0012 g) Yeast, Unspecified (12.6 g) Niacinamide (0.3 g) C13-14 Isoparaffin (0.24 g) Methylparaben (0.023 g) Glyceryl Stearate Se (0.48 g) Triisopropanolamine (7 g) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (0.004 g) Inactive Ingredients Edetate Disodium Anhydrous Sodium Sulfate Sodium Benzoate Magnesium Aluminum Silicate Potassium Sorbate Pyridoxine Hydrochloride Sodium Laureth Sulfate Magnesium Chloride Magnesium Nitrate Thiamine Hydrochloride Identifiers & Packaging Marketing Status OTC MONOGRAPH FINAL Active Since 2022-10-20 Until 2028-02-03 Medication Information Warnings and Precautions Indications and Usage Dosage and Administration Section 50565-1 Section 50570-1 Section 51727-6 Section 51945-4 Section 55105-1 Section 55106-9 Structured Label Content Indications and Usage (34067-9) Dosage and Administration (34068-7) Warnings and Precautions (34071-1) Section 50565-1 (50565-1) Section 50570-1 (50570-1) Section 51727-6 (51727-6) Section 51945-4 (51945-4) Section 55105-1 (55105-1) Section 55106-9 (55106-9) Advanced Ingredient Data [{"name": "ARCTIUM LAPPA ROOT", "unii": "597E9BI3Z3", 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"strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C13-14 ISOPARAFFIN", "unii": "E4F12ROE70", "classCode": "ACTIB", "strengthNumerator": "0.48", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "ACTIB", "strengthNumerator": "0.48", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERYL STEARATE SE", "unii": "FCZ5MH785I", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TRIISOPROPANOLAMINE", "unii": "W9EN9DLM98", "classCode": "ACTIB", "strengthNumerator": "0.004", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)", "unii": "255PIF62MS", "classCode": "ACTIB", "strengthNumerator": "0.0012", "strengthDenominator": "200", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}] Raw Label Data All Sections (JSON) {} Additional Information Back to search View SPL set listing Open on DailyMed ↗ Source: dailymed · Ingested: 2026-02-15T12:01:13.299545 · Updated: 2026-03-14T23:01:17.657881